Quality Assurance & Compliance

Conduct internal audits of GMP, GCP, GLP, and GDP operations. Prepare facilities for regulatory inspections (FDA, EMA, PMDA). Manage CAPA systems, track audit observations, and ensure facilities maintain inspection readiness year-round.

Review batch records, analytical results, and deviation history to make lot release decisions. Ensure every batch meets specifications, all deviations are resolved, and regulatory requirements for release are satisfied. In the EU, serve as Qualified Person (QP) certifying each batch.